Earnings call transcript Q1 2023

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Operator

Good day, and welcome to the Travere Therapeutics First Quarter 2023 Financial Results and Corporate Update Conference Call. Today's conference is being recorded.

At this time, I would like to turn the conference call over to Vice President of Investor Relations, Naomi Eichenbaum. Please go ahead, Naomi.

Naomi Eichenbaum

Thank you. afternoon. Good Travere XXXX to corporate results first call. update Therapeutics welcome financial quarter and And be our led Dr. will call Today's by Chief Officer, Executive Eric Dube. will the Eric in by joined Dr. prepared remarks be Chief Chief Financial Chief our Jula Heerma, Officer. Officer; Chris our and our Inrig, Cline, Commercial Medical Officer; Peter Dr. the Senior for President join Vice Rote, Research and session. Bill will Development of us Q&A

statements harbor we I would not statements of call this during that Securities begin, Act like are that Litigation safe Before of regarding facts historical within the Private forward-looking XXXX. are made provisions to remind the matters Reform everyone

They statement Forward-looking assumptions known statements issued press forward-looking the SEC. are the the results, differ not guarantees XX-Q well cause or our as may those unknown of performance, the see disclaimer and earlier Factors as XX-K statement. release performance. implied uncertainties, section from achievements in and to Risk Forms the involve company's materially risks, actual and today, and with on that expressed by filed Please

forward-looking any views future May the such Travere statements our addition, events, to reflect such circumstances. In information, of statements specifically made, or XXXX, and update to statements X, any only date obligation are as disclaims represent

me Eric? let the that, to turn Eric. With over call now

Eric Dube

Thank and afternoon, you, Naomi, everyone. good

adults IgA in nephropathy or led approval quarter FILSPARI the of of growth The bolstered of risk reduction by proteinuria continued the for progression pipeline. progression. representing notable with by significant the organization. nephropathy disease the was or of of launch has progress our primary accelerated US at and XXXX first most sustained in the the ongoing quarter IgAN rapid The Sparsentan achievements FILSPARI of across Travere the positioned These one been critical IgA in for milestones advancements of have

reduction The approval first for of marked only proteinuria the and the IgAN. therapy in of non-immunosuppressive FILSPARI

from well we the on I'm progressing position While line launch takeaways executions, we Though will the to and the first year. goals Today or with we focus and stages, meet in commercial will the effectively very very demand the the the expectations. only internal is important organization's early that are our FILSPARI for our in pleased early commercial weeks. six with confidence instills which exceed

excited Furthermore, study from the elucidate the to active the results XX reduction of the baseline These very profile demonstrating than after compared treatment the PROTECT data weeks were Lancet. published a threefold irbesartan. see interim clinical in of from FILSPARI proteinuria we of greater further control to

did support a the quarter the the efforts outcome Overall, our compelling endpoints it year. The in IgAN FSGS in was to this standard fourth disappointed to a in in report quarter DUPLEX positive week, a of Earlier for confidence Study the FILSPARI to not from dataset this of great X efficacy foundation establish secondary primary for of achieve new become eGFR endpoints. sparsentan two-year we our that for addressable population. treatment Phase our were the

by a a FSGS managed and profile disease still demonstrate study. sparsentan this, proteinuria a Despite is difficult reduction two over safety consistent characterized profile well-tolerated to very sustained to years.

datasets future and on update provide FDA to direction. potential and in the explore the regulatory our engage analyze to with will an for we've continue Once will We we this, FSGS. the completed submissions EMA

encouraged to HCU. or by momentum program continue homocystinuria With be pegtibatinase, to regard our for classical highly we classical the in forward

to serious complications. many and progressive mental a serious and bone can As disorder events, lens dislocations, recall, vision psychiatric problems you will a constellation thrombotic and due lead metabolic of that malformation, of to HCU is

positioned to the is first pegtibatinase approach modifying disease and well potentially become only to HCU. Importantly, treat

second from quarter. track on cohort-X the made program We our in to in strides have data recent remain and report

diseases the supported in for with of us needs. have therapeutic We who our physicians patients, pursuit are members, advancements incredibly to family grateful high and unmet

mission lives our the our with to of rare committed community, disease, those for for the and improving rare shareholders. our disease Our living team patients delivering of remains

over a turn Jula? for me let call Now, clinical to the Jula update.

Jula Inrig

Thank you, Eric, and good afternoon, everyone.

of I'll to highlighting the clinical FILSPARI education start the our support profile. by awareness and continued efforts

very Phase As recent in nephropathy. with the publication interim the earlier, interim in publication were and study of Eric the to Journal rapid results the IgA PROTECT speaks from X pleased this scientific The renowned of the we strength mentioned PROTECT Lancet. in relevance results the

highlighted its The kind to published along detailed and from showcase reductions sustained nephropathy. complete the and partial results partial of data inclusion data The study the XX interventional greater FILSPARI publication largest as significantly remission and proportion interim significant a the of weeks in results PROTECT on the complete in in new proteinuria remission. great proteinuria. after of a platform The with rapid serves that achieved PROTECT, on PROTECT IgA new patients treatment of seen of of

levels most IgAN their proteinuria As lower impact less day can grams within X.X failure reducing kidney kidney lifetime, maintaining recently outcomes. will face long published, to thresholds of high risk than term patients and per particularly and

also We encouraging on important early kidney saw outcomes. trends

in to XX% the kidney Here number the eGFR irbesartan. FILSPARI treated with approximately half failure all-cause of or baseline reduction from reached patients confirmed mortality compared

function with that important primary protective belief effects study sparsentan the and may the Furthermore, kidney included PROTECT X support hemodynamics. efficacy optimally endothelin-X that the Phase beyond structure antagonizing our and in lead were objective and data of angiotensin-X to

proteinuria the be reduction in proteinuria is differences authors to that relative to of differences unlikely to differences conclusion pressure the attributable through lowering sparsentan in blood pressure. the given minimal especially the in large effect Specifically, blood

discontinuations treatment analysis, events arms. of also weight difference of publication analysis, between change which no the and the in included safety interim treatment from reported data heart edema, no of significant adverse peripheral the Finally, serious cases time no at or additional the failure

from for interim line benefit expected readout on study for between interim significant PROTECT and the steadfast patient to results the report clinically support and as two literature the eGFR demonstrating preliminary the eGFR fourth sparsentan. meaningful data I'm statistically quarter confidence eGFR accrue track after top years the year. clinical continues that data treatment with scheduled on in a the of remains published this our proteinuria of These analysis to pleased and treatment relationship and reduction and the effect

accelerated approval, FILSPARI's patients, from the including and solid received support advocacy nephrology physicians, Since also groups. community, we've

Following a nephrologists the an learned their The at reason publication prescribe MKS, sparsentan IgAN to behind that academic was to a start of decision discussion primary patients. I Lancet eligible with for handful

it's way as receiving including intend now are similar We treatment their patients anecdotes available. option a that to the alter by physicians they that that FILSPARI treat key

treatment now and to FILSPARI included is in leading tool physicians. an Importantly, for industry for up recommendations support date, clinical decision IgAN the

us RAS treated by recommend or patients be the adding after authors forward We proteinuria physician call months put briefly development SGLTX RAS confirmatory study on inhibitor strong the three look to an persistent that the enable with an but which new The in Phase touch of PROTECT a we hosted become data, foundational sparsentan therapy to in switching X in only to FILSPARI recently believe FILSPARI. update position to inhibitor six to IgAN. will inhibitors FSGS. eagerly We

report were significance DUPLEX proteinuria studies. study it that we across on consistent of statistical disappointed the the While achieve not reduction did XX% to endpoint, did eGFR demonstrate

with sparsentan well higher that saw also dose, be we to continued Importantly, the tolerated.

the had forward supports with our US a patient study nephrologists the with and positive combined chance a seen to in in path we both trends the and reported we've engage motivation seeking encouraging. supportive our Since further and regulators been feedback community. This has in both results The Europe. resounding with the

we sparsentan, homocystinuria. to program continue pegtibatinase Beyond advance classical in our

dramatically As you total dose. an kilogram many with Compose milligrams homocysteine response, our of recall, in first dose-dependent X X.X the per reduce of a Phase cohorts to ability Study, will demonstrated clinically X, five levels to meaningful ongoing pegtibatinase a

Importantly, pegtibatinase to show a was generally well-tolerated safety able profile.

of six aid formulation, program's the our for will higher design discussions In steps and a X year. this in second cohort the to and give dose we're valuable potentially with which regulators us the insights of next Phase examining initiate a study the lyophilized regarding half

quarter update an our plan data we've and look the new support physicians a to recent to treatment update program community and HCU in progress are now options later disease-modifying that for next hear on pivotal program provide an Additionally, to We the commercialization. regarding we year. needed sharing those ever from more later steps so and on patient made than desperately and manufacturing this this forward

over With the to Peter the call for commercial that, update. Peter? turn I'll

Peter Heerma

Jula. you, Thank

progress to I are early that pleased report we great the days in of making am FILSPARI launch.

and results weeks, the quarter six we line Our in with included our expectations. are only in first

encouraged the payers. are We interest seeing engagements physicians, patients, that we're with strong and including level across of and stakeholders,

we Let of metrics saw in progress and the the of six that the end of first approval on QX. until weeks me reflect our some

both that February securing positive and patient of approval remained in we longest first the reimbursement FILSPARI efficacy XX, three Educating on with broad Since our priorities. FILSPARI. focused by on have physicians access have and experience and coverage safety ensuring profile nephrologists enabling a our patients

physician our efforts. education at looking First,

nephrologists Our on over commercial to professionals XX seasoned label. of and access field team educating getting successful them the is FILSPARI in

Our the IgAN strategy ultimately roughly the FILSPARI X,XXX population is to nephrologists addressable representing of patient universe the of XX% in US. reach for

and engagements the and of profiling believe those the over been insights to We early we X,XXX be aligned interactions nephrologists these with in will have weeks. six face-to-face nephrologists are have first adopters. who These reaching we our are

And has now the a impressive The increase the and we having see our that the team Physicians importance reduction reception brand and strong with to awareness, to been excited FILSPARI's discussing of with profile actively strong. nephrologists. therapy. FILSPARI agent safety efficacy mentioned FILSPARI in proteinuria consistently are is non-immunosuppressive

that FILSPARI in call, shipped which eight the on from patient day the our about first days just we forms after after and we patients working last working first the only mentioned As start approval. the educating product the started physicians was was received approval, to also day earnings first

that our FILSPARI bonds and with first from We our analysis. has is These reduction that the six was observed are it and we're going this anecdotically early of first steadfast how patients team interim the what over prescribers treated be from energize rapid stories hear educating encouraging team. PROTECT heard the to FILSPARI conserving proteinuria consistent patient incredibly and may treatment. with he stakeholders demonstrated is weeks is still in one This benefiting starting dedicated

identified In Total from getting patient XXX the Travere FILSPARI. and of they benefit physicians weeks, can enrolled have start we the receives forms increasing who patients Care an number first program REMS see because in six

failure. in making we leading are as Secondly, for educating the disease kidney payers pulmonary robust rare on progress IgAN

to indicator patients meaningful IgAN that years Within progress infield value kidney for of proteinuria to the and of failure accountings payers. is a XX disease the compelling most many within to forms years context, that our FILSPARI's XX And diagnosis emphasizing progression. proposition prognostic

we P&T plans aligned are of a to their committees FILSPARI seeing and educational being policies. indication. FILSPARI As first specific FILSPARI including efforts, the formularies the is cohort are in these start discussed product result at This label's

coming through the will In diseases, six achieved the we newly processes. progress. access payer and periodically expand our will approved the In therapies to weeks, population. we we FILSPARI first prior for anticipate share is denied other coverage mainly months, through is coverage XX% appeal to and rare to authorization, of US continuing initial Similar continue

patients slow or experience We to are patients encouraged gain access. delay the support eligible we the with to to have provide claims which programs are products. rate with process, Consumer access able adjudication

The and mind rewarding launch Finally, personalized priority short is is Travere to patients is in caregivers REMS the in in comprehensive services journey. for proud over the experience about physicians the appreciation including other training process positive our easily the was a assistance co-pay patients. IgAN designed patient reimbursement Travere accessible services. year through these process, in third through TotalCare patients' support providing for offered FILSPARI we for assistance TotalCare. And patient treatment It as I'm and in the feedback with education, eligible programs their

streamline process launch to designed services we and and True enrollment implementation TotalCare, to physicians the and patients. and Travere REMS support simplify for

physicians nephrologists from significant that points, to could they from a have hearing program patients in we earlier process because FILSPARI. REMS straightforward. of the are is REMS benefit that enrolling are We my identified seeing Hence, the number

starting of From a note based $X.X is specialty finished that perspective, the to net It predominantly financial we million. the of this pharmacies distribution is with channel. important FILSPARI on sales the quarter initial first

recall, may to of services high maintain for pharmacies utilize You patients. small specialty our we a network

One be distribution centers of pharmacies multiple selected the for to that to each demand. stock specialty for initial launch has ready regional the

be the As of and revenue. of we our impact quarter down anticipate in a portion second quarter drawn quarter that starting this, the a in will meaningful second this first result

The demand initial patients. FILSPARI's potential We're both to nephrology excitement that the IgAN see start. anticipate that I building. is begin demand we and more of view We indicate a and off to strong in metrics fourth shared a steady seeing of for will clear the trajectory quarter. third the in reimbursement Overall, that the a representative quarter community's launch believe I've

sustained in PROTECT The the of Lancet are the guidance getting nephrologists interim publication the FILSPARI experience and analysis, With confidence and that their the of and of proteinuria date. treatment inclusion the that reduction FILSPARI me are program still in recent continue to patients personal now number gives up the building own rapid the momentum. in enrolled nephrologists we with that REMS will

outside is connection the the with that continuing of commercial With FILSPARI, execution really our performance commercial pleased in team respect our to strong established portfolio. I'm

bile products quarter, organic XXXX. for million expectations reported our of Our which sales $XX.X with single-digit acid growth first is net product consistent in in the

quarter, net last in the same year. For in sales which comparable Thiola, period we reported first is the $XX.X to product million

really are year. our of importantly, commercial be We pleased FILSPARI is market spite reaching expectations. well performance adoption and initial competitive the in the start line progressing with we Summarizing, continue the patients with in Most to to the dynamics.

second And look quarters. the to trajectory more true expect work through the from third visible initial we stocking becoming the launch then to the the quarter and We fourth beginning forward in launch.

me call Chris over financial turn update. Chris? the Let for now the to

Christopher Cline

afternoon, and Peter, good you, everyone. Thank

was performance highlighted strengthening the execution as strong organization across the quarter first position. our of continued well as financial Our by

product For XXXX, first sales same the $XX.X the million net quarter from compared in period million to XXXX. $XX.X of were

the primarily is bile in attributable first to sales acid and portfolio. increase of FILSPARI sales The the of reported growth

As when our the methodology of for sell-in where pharmacies. FILSPARI, revenue network are we delivered we to recognize specialty products small utilized

of a the sales of FILSPARI large Peter, from anticipation to being quarter As amount in you related recognized and this has resulted demand. that stocking heard

of the legacy were beginning in we've years, coverage quarter previous to For insurance gross year. the in as products, the result changes the discounts of as in seen first net a higher

previous to Thiola As these we continue the the move business to higher for will year, normalize. in expect we through But years. they the balance of be than

to the prepare period product in nearly a they million goods the also license million by resulted The for $X we the primarily quarter, is $X.X This compares sold of also potential to activity During in drug our of recognized proportional and quarter. sale partner a same collaboration year. driven CSL launch of increase the revenue. increase This as cost for in Europe. Vifor of in FILSPARI last

first manufacturing XXXX. in the continued our Research expenses clinical million development programs $XX.X of $XX.X increased $XX.X is and basis, same pegtibatinase to period in of for including The clinical were attributable non-GAAP XXXX XXXX $XX On first difference same trial and adjusted and the to the headcount. quarter for expenses a largely of expenses million sparsentan XXXX. period R&D were million to quarter in million compared for the in compared the advancement

is in the approval in FILSPARI initiation first compared the launch the to supporting and million with and team difference the administrative activities, field General, the REMS services of were including onboarding inpatient for XXXX, program, launch-related the FILSPARI the to well the of staff quarter of expenses as as our quarter. million $XX.X $XX.X first Selling, same period XXXX largely for of attributable the

we SG&A $XX milestone to to a first Ligand of During paid the million were begin period the XXXX. $XX.X the non-GAAP On also expenses million compared adjusted to million FILSPARI. XXXX quarter amortize approval of $XX in payment same the upon for basis, for quarter,

in the attributable in in Total refinancing notes the million loss of $X.X XXXX, income an the extinguishment was interest to of by total $X.X is expense first partially of to convertible of offset difference other net same million debt net of quarter recognize XXXX, other March relating increase of compared for on our the XXXX income. to largely period a

per adjusted basis, in quarter basic loss basic a the same On a XXXX. of million period basic share $X.XX to the $XX.X non-GAAP was per $X.XX net net XXXX $X.XX or net or for was compared million first XXXX. $XX.X of same for per million XXXX loss loss for $XX of in first $X.XX share share for basic quarter $XX.X the share period million or or per to compared the of loss Net a

$XXX cash net of early $XX FILSPARI in of March we to offering reflects the approval from As which equity securities February. also the result $XXX.X of common million payment our made includes March XXXX, proceeds had XX, million of million, and marketable as the equivalents in company cash, Ligand a milestone in and underwritten

expenses to Looking moderately our that of operating increase may quarter-to-quarter balance anticipate the our variable be advance we will XXXX, we and programs. as

therapy of Importantly, FILSPARI HCU. we the the and will advancement disease-modifying focusing in potential pegtibatinase IgAN, first our be the investments in launch for as

We will our balance This further as our achievements in that operations dynamics remain potential in further I just cash anticipate can we this disciplined later for With highlighted well investments the year. related guidance financial FSGS while our into regulatory strong programs. payments towards the to work Thiola competitive as foundation, for and pegtibatinase, our support investment takes account and milestone into in XXXX. FILSPARI potential the we

now back Eric I'll call to for turn his closing comments. the Eric? over

Eric Dube

Thank you, Chris.

We accelerated first approval team of we six in with I'm the so for and well I in rare with reduction very are plan. access, the indicated the FILSPARI demand, is with approval and our with FDA disease patient in execution And of our treatment pleased from following first launch, expectations pipeline. The new patients of IgAN. and importantly, proteinuria non-immunosuppressive the our reimbursement, Most launch for am first far the line pleased with launch. executing how very weeks began the year marks on the our only

continues providing look regular on on launch. as updates to building amongst we momentum interest remain the quarterly will FILSPARI to focused nephrologists forward We grow and

a results as EGFR, topline of study the a in treatment to have achieving quarter the highly from this fourth look exciting final in this of remain on effect significant physicians the us are excited the we confident year those milestones to know, and forward ahead number We statistically see of also results, We year. PROTECT data.

to believe pleased second growth. we are review approval will and next with approval IgAN traditional in of results for sparsentan in of Europe positive half the the of Furthermore, look and catalyze to the year. potential phase We a EMA of regulatory forward lead FILSPARI the ongoing

are opportunity providing this eagerly we forward they Pegtibatinase become has for therapy to HCU. the the community been update later seeking quarter. to And first potential and program on finally, treatment effective in highly The are this the has and we approved, very modifying options. if excited an about disease population, underserved look HCU the

me to Q&A. back Naomi? let over Naomi turn call Now, for the

Naomi Eichenbaum

Operator, Eric. line open we can the Thanks, now Q&A? for

Operator

We'll Instructions] question of from line Maury is line now Jefferies. first [Operator take open. your the the Maury, Raycroft from

Maury Raycroft

Hi, PROTECT the per paper questions. progress an mil the congrats underlying on to per thanks on launch with translates my is per XX% to irbesartan for effect period. is that Based the Can minute year, and powered sparsentan clarify only of at Lancet so X.X treatment the taking the over detect mil is minute delta treatment a two-year X.X effect? if versus you that that or treatment

Eric Dube

turn Maury, thanks for the Jula. question. I over that to will

Jula Inrig

Maury, Thanks, question. for the

greater to XXX XX% year per detect than patients. power slope difference X.X a with the to So, of in mils per minute clarify,

more geometric X.XX%. just relative color. we is some XX% a and achieved achieving proteinuria recall, So This mean proteinuria difference ratio giving give us of data a reduction to based in in XX% on historical and a

incur predicts a close So when curve, on you to what that we slope originally difference modeled. put it the

more a point the and trial actually in you point if a details, with difference to can of that you anchor yourself. some I'll And modest for it high so a Even probability the predictive do appendix analysis slope. you I'll very eGFR sized positive want shows you

Maury Raycroft

the for IgAN view on a disease. think effect you treatment additional irbesartan can anything arm DUPLEX clarification. how eGFR we that Got PROTECT? us it. based point helpful should to data progressive size there That's the about is on and and Is new And

Jula Inrig

Well, on XX% in least PROTECT was They RAS. remember label, already the maxi-tolerated RAS optimized essentially inhibition. irbesartan at were

on So the to ones, despite an essentially, reduction were a was had those in treatment they failures still XX% we proteinuria in persistent there compared but they because proteinuria incremental And irbesartan. reduction relative proteinuria had this.

other So studies progress I those on better. can irbesartan anticipate we've may would seen be imagine slightly in we time that to

X would compared in reduction had per ml that that And the because per Maybe year. just what I historical in do they'll better is control. slightly they say, the to at minute TarPeostudy, progressed slight protein, than a we but

Maury Raycroft

sense. DUPLEX, on Got And miss it it. what slope on any question. okay That for you the to PROTECT? from I'm whether last total quick Similar wondering have stat maybe hit you be would FDA chronic if makes feedback slope do on

Eric Dube

take Bill, why don't that you question?

William Rote

and the the the from while So study we DUPLEX with that don't the is the the that study, around did have study. that around first discussions expectation PROTECT with of slope look they they in type designed elements want that, a design agency say my end, And specific chronic of each dialog the addressing they'd in Total program second, the be think of approach. to certainly all I with of at is consistent

Maury Raycroft

my okay. it, taking Got Thanks questions. for

Eric Dube

Thank you, Maury.

Operator

the will line the We take Greg Harrison from of open. next your line from question Greg, America. now is Bank of

Greg Harrison

patients color rate forms what afternoon. thanks are the give we on $X transitioned number be and expect the and what the of pain of maybe patient that or demand was time? maybe into additional patient million FILSPARI Congrats number able to portion on part sales over good have start treatment and many patients you at on XXX Are least for what how the the Hi, any taking then should to questions.

Eric Dube

the we of but recognize to of revenue get as medicine, variability terms going questions. as able patient quickly be how we in in that well have you're any you share start for early We to able thank about the well a the forms as position to mentioned to the talk would specialty you stocking on at to phase be certainly through. as as for be that in launch Greg, approval

think mentioned, some Chris take that. going and Peter time it I both to is have as And to

with patient we conversion or are that in very are specifics channel you They start re-orders providing going $X largely to regard point as to or line million with be demand, at did quarter. And breakdown of reflect reimbursement. about think have that forms of to we orders not any this can the underlying our While stocking expectations. first for some the

the with but throughout far, the of set lumpy and consistent We're in over launch. first all can metrics make We of of provide are going launch. that launch the really predictable consistent that the part really sure to so time are want we pleased to a aspects be those metrics

stay evolve tuned, point, XXX, underlying we reflecting share you able have may but this an is on that launch, being emerge rely of and So to that from would the some nephrologists. in I say should the trend we at the underlying demand

Greg Harrison

then fair enough. Okay, it's pretty And the XXX impressive. number,

above from people's expectations. Do expect a I patients think all bolus was you treatment at ramp reflects of do think waiting more it's steady that a most throughout or maybe for here? of that you

Eric Dube

why Peter, one? that you don't take

Peter Heerma

Yes, see And to still really disease do handful Greg, nephropathy you don't of every bolus. happy that. a rare a that IgA nephropathy even for to Yes, IgA question. has have though a patients. at Thanks you realize least nephrologist

patients top those date. of come hi, has like, should all like physician a a in mind not It's at certain

us after say, to spending how for in have seeing and top IgA some I time of those community So are, nephropathy especially busy mind. the is practices field

all in a have fraction, so serving, they some nephrology don't For are patients those only it's think I small bolus. they

growing we demands as with office bolus steady there are coming IgA wouldn't is the you progress well. seeing big with as in happy regards say into constant see to patients steady I you patients see demand advance. the a a that is I think a and nephropathy are that demand initially, are we We as there of will But

Greg Harrison

the questions. Okay, Thanks great. taking for

Eric Dube

you, Thank Greg.

Operator

Joseph, We Joseph the is of take your question open. the Securities. next will line line SVB Schwartz now from from

Joseph Schwartz

date insight Hi, thanks describe you can FILSPARI have the a how adopters physicians earliest us? so can to and much. I written give you any was if us many for if wondering prescription into

Eric Dube

don't why take that question? you Peter,

Peter Heerma

at Yes, point, this years have. point, be how we disclosing prescribers we to many earlier won't

already. We prescriptions have seen repeat

is with the in We're point, your to think I you pleased very may of the it's have start XXX And profile way what prescribers the receiving given with so the product right far? expected forms. now. they're line the what patients

as Well, FILSPARI. key on clinic, as community based behavior practices that we -- of well volume as physician's is in aspects. the prescribe have really targeting patients volume, well three One And large especially see influence. the been we innovation adaptation physicians in patient are as new the in to the the

Joseph Schwartz

Okay. Thank be program. can these you. then somewhat hear We that And your question maybe HCU a elusive. on patients

relationship that much since describe I and has you was it physicians with to III them to evolved And the and treat -- be if a think that patient larger So enroll running wondering was the enroll? you compose community that could how the study, you challenge your how of do challenging can study? how Phase think a

Eric Dube

ask Joe, is Yes. start patient relationship that thank I'll community Compose to has in sharing and the the share really you a has for underserved. great Study. community of Jula This been about gathered the insights a bit by evolved, little team then the has question. some I'll how conducting and the that her

conditions took we've we the PKU a actually of many program, them are over with served when similarities, phenylketonuria lot And of community and as I the because or But were think the managed. really of connecting by to as start as well organizations, advocacy build online our of them, they as the kind here both started relationship in with community their US as the well own how to really patient with build abroad. standard

a think see that articulate improving of trials more a educating organized we're with are the newborn as the diagnosis helping earlier a concerted to needs to I what that in better disease, screening, community in much starting effort and understand engaging And, I of the to management potential clinical as as future. about well us think for importance innovation of regard to for the

And gained trial community more. I learnings to largely evolved. share the to turn pleased think to I we've that been regard has over a how with it So, will good And enrollment. we've lot Jula with really quickly of with I really think clinical

Jula Inrig

be Thanks, Eric. to disease, Well, per challenging it any recruit few very can patients because there's rare site.

patient So, community provide partners your the a need a do to lot of engage patients to to really take are to it design and them. what's understand have you can often important you where support. bit trial Simplify advocacy the and to and longer them with go with the and

And what doing. so that's we're

would And that that the natural if provide enroll I patients to the can them forward, bit Moving sure help into with helps history interested with who a make then design study. incorporate what say having engagement have what's with we to the to that also important to that have key significant they're we we a study us participating opinion additional leaders importantly quicker. also patients of access in us can patient their community is and

Joseph Schwartz

the Thank insights. you for

Eric Dube

Joe. Thanks,

Operator

We will the the Carter, Gould open. line take Barclays. of from is now line Carter next question from your

Leon Wang

And Hi, Carter. Wang the Leon my question taking this congrats on results. on thanks and for is for

on FILSPARI, they may waiting not docs any eGFR confirmatory for data are the of early a any that launch? signs prioritizing be for profiles to susceptive perhaps So, of waiting or show maybe more that profile docs and those versus that the patient data

Eric Dube

Yes, thanks and by where saying question. adopters have Maybe will early launch, for are those you with physicians of that adoption spectrum by that are I'll any start the some waiting great typically you a see that.

with physicians very that pleased will with in expectations, What wait. is line surprising also will physicians some we're and is launches. say it's thus and So be that the experience performance my I far there in from not our to that absolutely want

the we we're see physicians I'll of seeing, six to as as weeks a more prescribed well that little the the first share about adopting. ask FILSPARI that in Peter patients bit profile of types

Peter Heerma

that color seeing. Yes, the provide think, basis some we I to happy on

lower levels those the the rapid but majority at progression patients indicators for patients the some X.X, we patients has have proteinuria have are that So Many of with restrictions on majority, which additional progression. levels. those rapid pace consistent high are X.X the proteinuria but vast for also of of above are

nearly the gram. I how X.X with largely indication in So think some line is X.X so with written, above below

Eric Dube

Maybe the other what add the of payer thing, with is consistent commercial had assumed having these very Peter with that we patients that is insurance. the majority I'll mix

did I in looks our team again So look with much the very that to work is line what lot like, really this a and expectations of uptake think could Peter's like, what planning. launch the profile

Leon Wang

you. Thank right. All

Eric Dube

you. Thank

Operator

from Bayko Liisa from the next take Evercore is of question your ISI. will Lisa, line now We the open. line

Liisa Bayko

Hi my initial there, the start good call, on and congratulations thanks for here. taking

now, know year, initially and this you what about net I and it stabilize what kind of gross do what you but -- then quarter, think of later wouldn't think can but as I'm sure expect, will would not the sort about we we this and in around? have be Just it right and

Eric Dube

Yes, great of part a you first to quite question, Certainly going Liisa. launch as to is be lumpy. the alluded

to ask steady to reluctant been state. on we at to we provide we've Chris landing point, get think once where but this estimates be So may we that I'll comment any

Christopher Cline

getting Yes, at And reflective Really once for of state. looking question, state. us seeing mid to thanks think Liisa. stable going we We're to to we're stable a is do there, now the be what I high that teens. get

that from expectations change point. no on our So,

Liisa Bayko

then PROTECT And back and Okay. the just to your powering.

a bigger but can actually you difference Jula, you're milli was saw, describe you that assuming than difference a XX% proteinuria you X.X for So, you got delta in powered that how liter saw that. X.X slope was

have should little confusing? said, hear -- that So difference. right you about I to didn't everything it Can a the you was think way just that? now Is you greater

Eric Dube

would you Jula, like Yes, take to that?

Jula Inrig

Well, power on can our was data. then data. the on incurred historical it based you calculation initial based map And

be we years. in power at data statistically to clinically incurred on based to meaningful and So line original two able calculations our significant predict with effect a fall

after The is focused benefit do approval, this the to of to as part to accelerated other confirm add the be want review FDA able our was two for we'd years. that our very that I thing

the the us the at provided likelihood slope on of that we available significance, conditional time the as to information data significance trial analysis. two the as eGFR of and our requests, their from total power the both the interim address statistical a at well power statistical calculation for chronic year, analysis high importantly so level looked confirmatory on at confidence asked provide they level year two the endpoints So achieving conditional of the calculation achieving and very

Liisa Bayko

thanks. Okay,

Eric Dube

Liisa. Thanks,

Operator

Wells from the line the question Bansal your now of open. will Mohit, Mohit Fargo. is take next We from line

Unidentified Analyst

the think This of FILSPARI of Thanks the naive covered, we type that quarter for to first year that you and here, whether the then of And could is insured questions. from that [indiscernible] how you cadence your being lives launch? taking demand going for switching about discuss of ahead expectations on to patients in at think on patients from X% separately, quarter. or Mohit. our is bigger is the Can driver

Eric Dube

Sure. two Peter, questions? you why don't take those

Peter Heerma

question. for Thanks the Yes.

ACE So and when in you based regards coming with switched the the majority from patients the or FILSPARI. naive think demand main switch. It about like to the have those AR majority, is where are to of past or complex, been patients, is very on like vast

So I quite think consistent. is that

start naive well. I as see think will ultimately to you patients

because of I majority patient are of the are think the fraction the population, of in small prevalent it's offices physician. patients those already the a total

that levels once. your seeing position been So now phenomenon, FILSPARI we're much And part squarely proteinuria being that the question. still of is, so first limited what works that we're with to patients sport at are have of replaced right not was the

the of weeks only the with it's if it's there line a especially With regards XX% expectation, to into and was XX% six number consideration good after XX. or second much part coverage, that March take coverage our in by you

think a and that see good I feel of what I benchmark you products. at we it with So the is proud quite number high end, think it's

Eric Dube

regard to indication. really have both just relative labeled Yes, would the payer important And those the The the ARB. Peter. add the are access patients really of as majority patients stepped But to you quality to we're there's or actually not ACE that the is to a the number coverage. Peter the aligned ARB. again, on and think about we for that. of payers those Adam. thing to coverage when It's that I questions already degree only do think of for of see of quality Thank coverage, through ACE or pleased what's alluded quality high these to, about with label a of see the we

referred many on nephrologists ARB. fact, patients or these of to ACE their are In

it's of it's and we're think quality actually when rest foundation that which coverage, upon quality look throughout I of actual pleased. build at to XX%, So access it's great we this but really a the not of just the year. the the Again early days, but

Operator

Laura question, Laura, Chico open. of Securities. next further line from We question take your line Wedbush will sir? the now from the is Any

Laura Chico

walk the of be maybe wanted guess timing to just missed from cadence going expectations it. product very I the ordering Like said to bit is there? little if is a receipt here. what actually talk dispensed? a timeframe a around the start more the form I I Sorry, to us differently. I when Could of are much. you what Thanks through guess, Eric, about

Eric Dube

a of little expect it's what Laura, about there year. I'll of range any throughout think a from dynamic where to and important it's the also great Yes. prescribing to for No, about rest bit and and seeing question, to talk is a what we launch Peter? specialty timelines Peter see we're this ask

Peter Heerma

to Yes. Laura for question. thanks that To that, respond

in access typical early launches. failure I I and think disease time a wide for to product rare call what longer. may Eric's Eric's the product especially points wide days to of launches. as many is There is many I the disease as range, for think range it's typical fulfilment to There's take point, rare a

XX is days get in the payer will to I in to typical a is which these pull-through I reach We in as days that time this diseases, but rare typically what would would days say. say, we more X anticipate XX range is coverage. fulfillment decrease FILSPARI

Laura Chico

Just And to verify. sorry, I'm Peter,

range. be typical correct? when ranging I XX XX. said Do it's XX You closer from to to a to But time have day that likely over

Peter Heerma

talking but disease verify that general, that in more let's in race. disease historically, It's rare are is what launches. rare I what in Laura. we will I've I seen in was about specialty Well, and say common

of I So reflective FILSPARI. not it's think

Eric Dube

Laura we've six I because as experience think we that after and important of What's team any well it that I should is, broader shrink coverage coverage, get as get start Peter's approval. numbers to coverage, average to high has continue that is the reduce. we already times and coverage growing more team one, and to to really first in time a to that aspect, mind execute regard think reimbursement, weeks and -- is in average keep as experience to off provide see as important think quality continues fill had, continue but specific important I the won't we're that what's only we'll with already lead the the we great to reduce time see we're that and to starting range is payer Peter's

again early days. So really

expect lumpy So exactly with it this see we seeing because the to don't successful is want dynamics we're numbers to but give would are you that what launch.

Laura Chico

many follow-up. at And apologies quick signed missed physicians REMS helpful. again, the point? in sneak did this that's up I you this, how one Okay, quantify but And are maybe I'll if for

Eric Dube

Peter?

Peter Heerma

we REMS understand REMS with FILSPARI patients, that see start No, forms I is it have the that process they with we as the their given we in understand and that assistance that that haven't relatively think may straightforward. the haven't, speaks to certifications very we're a enrollment steadily there, they but patient value also number the but pleased and increase for

Laura Chico

Thanks, guys. right. All

Eric Dube

Laura. Thanks,

Operator

Tim, your the William line from Lugo will of Blair. the Tim We from take line is next question now open.

Unidentified Analyst

Thanks Hi the for taking this questions. Tim. for guys, [Lachlan] is on

headwinds obviously been that have had heading well data much really very was the into headwinds or guys released. you there's have I just because not one of wouldn't mentioned physicians the guess So launch, potential the

interactions how affecting into far. right, or I guess how just physicians really so much that you what are guess expected? I'm So compared prescribe sort the seen Have the that wondering has to launch data not affecting that or which is maybe of the I any to played you of that, starting

Eric Dube

the understanding that the FILSPARI? on think really you Yes, a think you're of Peter, why high it's what a to share question, going through don't great hearing data a about publication Lachlan. team about profile what but, bit Jula data interim the I'll having I from physicians a data first in more about better But little gives your I point mentioned

Peter Heerma

I Yes, know, so. to happy do

is seen as maybe I to social general in inclined that So general. much with nephrology think with particular nephrology not innovation And that's indeed specialties other we innovation that rare in and a given like in launches. have phenomenon nephrology launches other some

publication specifics. having of kind To six or launched new very rolling without Eric's without not data of a which this having launch sort a the without in product a weeks having common is first I date, think launch that point, to because like and we is

we the And launched so PI. basically on

lands in in in the Brazil up date mentioned restrictions now as that of I But publication given that part accelerated prepared well. inclusion confidence like as and have Jula the product should and provides medicine that support in and more insights think promotional of start her we a approval. process remarks, Also the in guidance to provide

but I'm also -- patients XXX very Loreto. prescribe I'm the pleased actual we for in with the that's were think in seeing I we and prescriptions that thought to across So intent ready, the what both being

accelerated and this more continue get those have to publications, the bring continued will we we confidence nephrology community shifts. for as and think allow and to data I

Eric Dube

Yes, I share I I in think quite customers. that's and and with Peter, absolutely the of can meeting you field spent two like additional right. Peter a bit time observations with maybe

when or because really of But help helps elevation in physicians I been absence a they rates profile was provide the information. publication physicians of in perspective. to perspective the actual the third put profile to think risk REMS really and and are in better I real the that what think It level eagerness the the and for is so some understand that the the think more and for is to into a I publication going aspect the the independent understand very rate other hard low and there's see that party of of AST reassuring to data FILSPARI ALT label. guidelines the really it's it of

Unidentified Analyst

you're of pushback there extent seeking maybe reimbursement that you you're been Got had most gone topic but delays, what some that it. from to payers? Thanks. think through And you The have the talk that guess, on patients can Peter, mentioned I for, I the about getting of there reimbursement. delays. were it

Peter Heerma

authorization through and that. it's so mean, goes longer. common disease wouldn't mean formulary as don't prior rare generally inclusion that say No, pathway in think it have a I in in I mean, I yet. particular. the I takes process I you

for wouldn't seeing that So obstacle like as particular FILSPARI. it indicate are we I

Unidentified Analyst

Got it. Thanks.

Eric Dube

Thanks a lot.

Operator

open. Guggenheim the next line Vamil now the is Securities. Vamil, from Divan of line from your take question We'll

Vamil Divan

the Great, thanks taking for questions.

so the comment if mentioning can that the think sense on to I that on SGLTXs per getting asked sort just of been or But terms in get than gram ANR most a early. more, one answered. and have dynamic. the label of terms mine of far, SGLTXs, trying launch obviously, in the are already gram. patients the I'm patients neuro on mentioned FILSPARIA with also real just you you And not? of greater curious But X.X just

sticking we just going to Chris, reasonable for about, a of was The spend a especially be should forward? amount then of the threshold? metric on below how sort that are even sort expense physicians guess, the Or And this quarter? to patients I this using think a with? first that judgment, little Is and more they side, Is SG&A seem that we assume quarter expecting. are second their just question bit maybe is than more were

Eric Dube

All on questions. the Vamil, the don't thanks why right. for the patients? you first Peter, take

Peter Heerma

Maybe many answering patients often giving because the you on perspective is XXs. by broader or diagnosed this those question of question. population. I'll their the good younger profile the early are start Like being XX a in patient patient Yes,

would physicians bring patients that see. the young the your Many point, didn't well. are what and as the of on target the is many and level available that. of rapid doesn't to seeing seeing medications patients do that we're to to ARBs to what ACE path that's progression Greg, And are current we level like

have SGLTX. You

we that I and increase as that see mentioned well in think something utilization we SGLTX. that's

as of with FILSPARI been decided physicians the it's physicians if this with immunosuppressive for combination without but physician not especially progression synergistic comfortable, FILSPARI you that profile talk rapid mechanistically of very go about or risk that feel SGLTX when proteinuria XX% patient SGLTX comfortable immunosuppression seen and very have makes quick, with especially especially if medications patient The has haven't human population. nature to also needed very is or of in the not appropriate combining

Eric Dube

for Chris expenses. And

Christopher Cline

think R&D. point to studies we going for probably PROTECT in balance R&D overall the pointed prepared Phase to that year, anticipate but well SG&A to for We and go then pegtibatinase as the I remarks Thanks supply about I DUPLEX of and the and III done into and the to really expenses. needs work both up III of the for about scale are to more work of back be you What is for year would also Phase of to for that continue as look when Vamil. CMC the Yes, going initiation That's all balance as talked breakdown the that's a commercial. both absolutely. the on question, continue potential moderate the the towards increases the

likely comp magnitude think so I of the that's year. increase where see larger for And you'll the

activity magnitude point, to there I may first the promotional sales can position wouldn't the force fully I from modest had IgA. this quarter doing we've appropriately think for the this be FILSPARI first time of from that what significant an really it make SG&A but gotten which to is and in you any full right and in place some be increase we putting all expect investment behind to it in perspective, sure

Vamil Divan

Okay, great. Thank you.

Eric Dube

you. Thank

Operator

the from We'll question Stifel. Alex from line the take next Thompson Alex. of

Your now open. is line

Alex Thompson

physicians seeing any than it writing qualitatively by And ask of or I multiple the bit if of question and try sort you another for Thanks a for Can then whether start one you my comment on one higher to cardio Thanks. flexibility prescribers. or a about FSGS. and Hi, multiple of guess, sort in I'll targeting talk coming analysis physicians of so within rare given question. lot them on the Start questions. looking diseases, volume from is you're majority there's IgAN question. precedents far on taking historic I that is starting that? you're dynamics FSGS Can subgroup especially. little IgAN, single for broader division the patients forms commercial a got I that guess Forms sort good towards of great. renal

Eric Dube

to would the right, Thanks you for question? IgAN Alex. All the questions. take like Peter,

Peter Heerma

Yes. Thanks, Alex.

the or prescriptions understand and mainly if have it's prescribers So you if like, your had in higher multiple centers. question your correctly, prescriptions question I volume from was single do more see mainly

for that. specific to early statement it's give think me I a on

or community second a we see majority centers, of on see the and from centers of physicians I the that centers the also coming larger the especially community academic time prescribed single prescriptions time. prescription think but mix from see have we we from

it's days So, early on but again describing this think six the weeks. and for prescribing I first this

wouldn't I prescriptions it. We see So into single base see both those prescribers. prescriber read well as as we a and large multiple much too among

Eric Dube

question why you the take Bill, flexibility? don't on regulatory And

William Rote

No, happy Yes. to.

think to I the one mind Entresto congestive that cardio renal. comes failure quickly approved is for by heart was

that and agency I is their across of there primary totality something improvement. memory that need decision clear the 'XX evidence in and drug missed was my interested trial unmet that think the that was but were a was they of in endpoint, on was based benefit if that the right and

I disease there that think have instances indications. across other rare been

XX% approved of the years study. the read think about their the FDA drugs they I JAMA in work years And primary past the about in said missed most that X their endpoint recent I that where by pivotal were or XX was ones

norm a also not of. something unheard not it's it's So but that's

Eric Dube

anything to on that question? And Jula, like further add that you'd

Jula Inrig

another for also Migalastat would is to reference. to I potential point another indication look Fabry at

Alex Thompson

Great, much. so helpful. Thanks

Eric Dube

you. Thank

Operator

Wainwright. from next question the We now will from open. take of line line Arce Your HC the Ed Ed, is

Ed Arce

here already the demand prescriptions recognize metrics on are or a and it's highly through and Great. sort in number as perhaps here. pointed weeks, compliance million example, is the at if variable so -- represents mostly rate mostly squeezing around see you later obviously and get you wondering out six I'm that's first or specific for but persistence on we regularly, me early patients PSS report drugs we've I launch And launch. years, I then XXX next for conversion few of the as there you and $X said fulfillment intend the or that as and to on Thanks numbers that beginning the congratulations quarters progress stocking first. of rate discussed on the just

PK Thanks is as the the the new ask as lyophilized to what from quarter that this the as well The formulation. secondly, dose so partly formulation. on quarter? data the on on could look just later higher aspects readout, readout in clearly with HCU then wanted to expect focus with we the efficacy later well other And this But dose much. the these

Eric Dube

for Ed, Thanks, I'll first the one. Yes, take thanks. great questions. the

are metrics, us at sure and So I sort ones that certainly think have that looking are trendability on metrics robust patient pull why a the We forms the underlying provide different because confidence and and those start the number reimbursed. important we believe as are really through predictability. as we it's focused that's of of well demand we the of that for ability make we in to access regularly predictors and they to have

rate to likely we you high commercial rates as think look may I you we like persistence and have can et can our reimbursement the the rate forward, others or talked persistence about there persistence be where business will the of look that imagine there cetera.

sure those this will important we to FILSPARI as in again fundamentals launch. make want most on what the that we of be first evolve believe underlying we the focus understand that we year of the to year look are, dynamics but to are we to So going start launch, really those

Bill, will And yet specifically. we I would further X then of readout Compose be disclosing, in cohort you to with the for, Study, on what be possibly we'll looking Bill? we I'll to say provide the what we committed disclose some to but and will haven't perspective turn regard what to the

William Rote

Compose dose-to-date cohort what we total formulation opportunity cohort biomarkers the XX-week we're homocysteine highest the for composed. predominant is utilized the to urea Study. X, also portion looking in lyophilized the basis is in evaluate view the the to in overtime in The in be the the final as the that per and on It What going in utilize study us patients. of almost or reduction homocysteine Sure. most double-blind a we in gave gig

those select dose tolerability. to the design to we're and X/X us rollover study. patients give at dose the will study for the Phase data at X that looking of and individuals and and that It's addition open those In of with help to the label then that, a that course, evaluating us will Phase the expansion safety into

Ed Arce

good. much. Sounds so Thank you

Eric Dube

Thank you.

Operator

will are turn at Eichenbaum, questions the no further additional back over remarks. you closing to I for There any time. Ms. conference this or

Naomi Eichenbaum

our day thank We for everyone first results look call. rest of forward to on and Have your us for financial you you. joining Thank a XXXX our great additional quarter providing updates progress.

Operator

you you may Thank participation and your now disconnect. call. today's for concludes This

Travere Therapeutics (TVTX) 4 May 232023 Q1 Earnings call transcript